Pursuing Truth and Transparency in America's Food System

Hugh Grant

Lawyers for Edwin Hardeman presented their closing argument today in U.S. District Court in San Francisco, asking jurors to punish Monsanto for failing to warn about the cancer risks of its Roundup herbicide.

Attorney Jennifer Moore presented the close for the plaintiff’s legal team, and Monsanto attorney Brian Stekloff made his closing argument, winding down a month-long trial that already recorded a first phase jury verdict finding Roundup was a “substantial factor” in causing Hardeman’s non-Hodgkin lymphoma.

The jury’s decision now is simply a matter of money – whether or not Monsanto should pay damages, including punitive damages, to Hardeman. Though jurors already decided Roundup caused the harm to Hardeman, they have yet to determine if Monsanto should be held responsible for that harm. The jury instructions call for jurors to answer three questions in order to be able to determine damages: Was Roundup’s design defective? Did Roundup lacked sufficient warning of potential risks? And was Monsanto negligent by not using reasonable care to warn about the risks posed by Roundup?

Monsanto’s attorneys have not changed their position that Roundup does not cause cancer. But for the issue of liability they have argued that during the period Hardeman used Roundup – from 1986 to 2012 – no regulatory or health organization required a warning on Roundup labels regarding cancer, and Monsanto had no evidence leading it to believe a warning was necessary.

In testimony Monday, former Monsanto Chairman Hugh Grant defended the company’s conduct surrounding Roundup though he acknowledged the company never did any epidemiology study of Roundup even though the company spent more than $1 billion annually researching new products.

“Monsanto acted responsibly,” company attorney Brian Stekloff told the jury last week. Telling jurors “this is not a popularity contest,” he said there was no evidence Monsanto acted negligently. “Monsanto, consistent with the science, consistent with how the science was being viewed around the rest of the world, did act responsibly and should not be found liable,” he said.

Hardeman’s attorneys have told jurors that there was a wealth of scientific evidence showing cancer risks associated with Roundup but Monsanto chose to try to suppress and/or discredit the information rather than warn customers like Hardeman.

If the jurors find that Monsanto is liable, the parties have already agreed to a figure of $200,967.10 for economic losses. But jurors could elect to add ‘noneconomic damages” to the tally, and they could add punitive damages.

Judge Vince Chhabria said in an earlier ruling that there was “a great deal of evidence” to support a punitive damages award against Monsanto and to show that the company “has not taken a responsible, objective approach to the safety of its product.”

The judge said there is “strong evidence from which a jury could conclude that Monsanto does not particularly care whether its product is in fact giving people cancer, focusing instead on manipulating public opinion and undermining anyone who raises genuine and legitimate concerns about the issue.”

In the first Roundup cancer trial, a jury last August awarded $289 million to plaintiff Dewayne “Lee” Johnson, though the judge reduced the verdict to $78 million.

Trimmed-Down Testimony as Monsanto Cancer Trial Winds Down

Lawyers for Edwin Hardeman have substantially cut down the number of witnesses and evidence to present to jurors who must decide if Monsanto and its new owner Bayer are liable for Hardeman’s development of non-Hodgkin lymphoma after years of use of Monsanto’s Roundup. They have but a few hours left allotted to them by the judge, who has said he expects closing arguments by Tuesday.

The six-member jury team decided last week that Roundup was in fact a substantial factor in causing Hardeman’s cancer. The trial is now focused on whether or not Monsanto should be blamed, and if so, how much – if anything – the company should pay Hardeman in damages.

But making that case may be difficult given the short amount of time the plaintiff’s attorneys have left in the total “time clock” that Judge Vince Chhabria set. He gave each side 30 hours to make their case.

Hardeman’s attorneys used most of their time in the first half of the trial and now have but a few remaining hours. As a result, they have informed the judge that they will not be calling planned testimony from Monsanto executives Daniel Goldstein, Steven Gould, David Heering, or Daniel Jenkins. They also will not be presenting planned testimony from Roger McClellan, editor of the scientific journal Critical Reviews in Toxicology (CRT), and at least four other witnesses.

McClellan was overseeing CRT when the journal published a series of papers in September 2016 that rebuked the finding by the International Agency for Research on Cancer (IARC) finding that glyphosate was a probable human carcinogen. The papers purported to be written by independent scientists who found that the weight of evidence showed the weed killer was unlikely to pose any carcinogenic risk to people. But internal Monsanto documents show that the papers were conceptualized from the outset as a strategy by Monsanto to discredit IARC. One of Monsanto’s top scientists not only reviewed the manuscripts but had a hand in drafting and editing them, though that was not disclosed by CRT.

Hardeman’s attorneys plan about three more hours of testimony from various witnesses, including former Monsanto Chairman and CEO Hugh Grant, who received an exit payment of about $32 million when Bayer AG bought Monsanto last summer.

Discussion of Damages

Both sides have already agreed that Hardeman has suffered a loss of approximately $200,000 in economic damages, but Hardeman’s attorneys are expected to ask for many tens of millions of dollars, and possibly hundreds of millions of dollars for total damages, including punitive.

Lawyers for Monsanto have objected to any discussion of Monsanto’s wealth and the $63 billion Bayer paid for Monsanto, but the judge has allowed some financial information to be shared with jurors.

Jurors may not ever be told exactly how much money Monsanto has made over the years in sales of its glyphosate herbicides, but a look at just one year of financials – 2012, the year Hardeman stopped using Roundup – shows the company made roughly $2 billion in total profits that year.

Judge Chhabria noted in discussions with attorneys out of the presence of the jury that Hardeman’s attorneys might want to argue that Monsanto spent a lot of money on advertising and payouts to executives rather than conducting long-term safety studies on its products. The money issues might be relevant to jurors’ deliberation over potential punitive damages, Chhabria said.

“It may be relevant to Monsanto’s ability to pay, but it seems even more relevant to the issue of what was knowable — both liability and punitive damages, whether Monsanto’s conduct was extreme and outrageous,” Judge Chhabria said. “Why can’t they argue, look at all the money Monsanto has been willing to spend on advertising and it’s not willing to, you know, conduct any sort of objective inquiry into the safety of its product.”

“It is not as much about the company’s ability to pay as it is about the company’s conduct with respect to the safety of its product,” Chhabria said. “Look at all these things that the company is spending extreme amounts of money on, and it’s not willing to lift a finger to conduct any sort of objective inquiry about the safety of its product. That, I assume, is their argument.”

Chhabria said the evidence of Monsanto’s finance could be “probative” of the “outrageousness of the company’s conduct.”

Pilliod Trial Beginning

A third Roundup cancer trial gets underway this week in Alameda County Superior Court in Oakland, California. Alva and Alberta Pilliod, husband and wife, take on Monsanto and Bayer with claims they both are suffering from non-Hodgkin lymphoma due to exposure to Monsanto’s Roundup products. Voir dire for jury selection begins today in Oakland and opening statements are expected to begin Thursday. See documents related to that case at this link.

The judge in the Pilliod case rejected Monsanto’s request to bifurcate the trial. The legal team presenting the Pilliod case includes Los Angeles attorney Brent Wisner, who gained notoriety for the win by plaintiff Dewayne “Lee” Johnson over Monsanto in the first-ever Roundup cancer trial last summer.

Cancer Victim Headed Back to the Stand

Plaintiff Edwin Hardeman took the stand today to offer more testimony in his lawsuit against Monsanto over claims his use of the company’s Roundup herbicide caused him to develop non-Hodgkin lymphoma.

Hardeman already testified in the first phase of the trial, which drew a unanimous jury verdict finding that Roundup was to blame for his cancer. His testimony today addressed the question of Monsanto’s liability and if the company should pay damages for the loss of his health.

Hardman’s attorneys are trying to convince jurors that Monsanto knew of the dangers of its products but actively worked to suppress that information through a variety of tactics, including pressuring regulators, ghostwriting scientific literature, and misleading consumers such as Hardeman with heavy marketing about the safety of glyphosate-based herbicides.

In the first phase of the trial, Judge Vince Chhabria sharply limited testimony about Hardeman’s medical treatments and the suffering he endured. In this phase, such testimony is allowed.

Jurors also heard from Mary Hardeman, Edwin’s wife, on Friday. In the first phase, which dealt only with evidence pertaining to whether or not Roundup caused Mr. Hardeman’s cancer, the judge rebuked Hardeman’s attorney Aimee Wagstaff for even trying to introduce Mary Hardeman to jurors and for describing the couple’s courtship and long marriage.

Hepatitis C and… Hugh Grant?

Monsanto’s legal team on Monday presented testimony from Dr. Alexandra Levine, a hematologist/oncologist with City of Hope Comprehensive Cancer Center, seeking to convince the jury that exposure to glyphosate-based herbicides was not a cause of Hardeman’s cancer, and that a more likely factor is the hepatitis C Hardeman had for many years. Levine testified that she has seen “many, many, thousands of patients with non-Hodgkin’s lymphoma,” and she is in fact considered a specialist in that specific disease.

Judge Chhabria said last week that he would like to see this first phase of the trial wrapped up early this week, meaning the case should be with the jury soon. A verdict requires all six jurors to be unanimous in their finding regarding whether or not Hardeman’s exposure to Roundup “was a substantial factor” in causing his cancer. The judge will define for jurors what that means. (See Friday’s entry for more details.)

If the jury does not unanimously decide either for Hardeman or Monsanto then the case would be a mistrial. Chhabria has also said that if that happens he is considering retrying it in May.

If the jury finds for Hardeman on causation, the trial would quickly move into Phase II using the same jury. And that is where things will really start to get interesting. Hardeman’s attorneys plan to call several Monsanto executives for testimony, including former Monsanto Chairman and CEO Hugh Grant. Grant spent more than 35 years at the company and was named CEO in 2003. He led the company until its acquisition by Bayer AG last summer.

Additionally, lawyers for Hardeman plan to call Roger McClellan, editor of the scientific journal Critical Reviews in Toxicology (CRT), which published a series of papers in September 2016 that rebuked the finding by the International Agency for Research on Cancer (IARC) finding that glyphosate was a probable human carcinogen. The papers purported to be written by independent scientists who found that the weight of evidence showed the weed killer was unlikely to pose any carcinogenic risk to people.

However, internal Monsanto documents show that the papers were conceptualized from the outset as a strategy by Monsanto to discredit IARC. One of Monsanto’s top scientists not only reviewed the manuscripts but had a hand in drafting and editing them, though that was not disclosed by CRT.

Hardeman’s lawyers additionally said they plan to call Doreen Manchester, of CropLife America, the agrochemical industry’s lobbying organization. Manchester’s role at CropLife has been helping “lead federal and state litigation to support pesticide regulatory issues.”

How Monsanto Manufactured ‘Outrage’ at IARC over Cancer Classification

Three years ago this month Monsanto executives realized they had a big problem on their hands.

It was September 2014 and the company’s top-selling chemical, the weed killer called glyphosate that is the foundation for Monsanto’s branded Roundup products, had been selected as one among a handful of pesticides to undergo scrutiny by the World Health Organization’s International Agency for Research on Cancer (IARC). Monsanto had spent decades fending off concerns about the safety of glyphosate and decrying scientific research indicating the chemical might cause cancer or other diseases. And even though the IARC review was still months away, Monsanto’s own scientists knew what the outcome would likely be—and they knew it wouldn’t be good.

Internal company records show not just the level of fear Monsanto had over the impending review, but notably that company officials fully expected IARC scientists would find at least some cancer connections to glyphosate. Company scientists discussed the “vulnerability” that surrounded their efforts to defend glyphosate amid multiple unfavorable research findings in studies of people and animals exposed to the weed killer. In addition to epidemiology studies, “we also have potential vulnerabilities in the other areas that IARC will consider, namely, exposure, genetox and mode of action…” a Monsanto scientist wrote in October 2014. That same email discussed a need to find allies and arrange funding for a “fight”—all months before the IARC meeting in March 2015.

And Monsanto predicted internally before IARC even met that the review of the scientific evidence would result in a decision that glyphosate “possibly” was carcinogenic or “probably” was. Monsanto officials had forecast the IARC decision in an internal “preparedness” plan that warned colleagues to “assume and prepare for the outcome…” The document shows Monsanto thought it most likely that IARC would peg glyphosate as a “possible human carcinogen.” The rating of probable carcinogen was “possible but less likely,” the Monsanto memo stated. IARC ultimately did classify glyphosate as “probably carcinogenic to humans.”

As the IARC meeting loomed, the internal documents show that Monsanto did not wait for the actual IARC decision before acting. It enlisted teams of PR and lobbying experts, scientists and others in a plan aimed at creating what was designed to appear as a storm of “outcry” and “outrage” to follow the IARC classification. IARC had a history of “questionable and politically charged rulings,” the Monsanto memo said.

The plan was to create enough controversy to thoroughly discredit IARC’s evaluation because Monsanto officials knew that regulators would be influenced by IARC, and continued widespread use of the top-selling chemical could be at risk.

The timing was critical because in 2015 both the U.S. Environmental Protection Agency (EPA) and the European Commission were evaluating re-authorizations of Monsanto’s weed killer. Following IARC’s classification, both the European Union and the EPA delayed final decisions on glyphosate amid the still-brewing debate over the chemical’s safety.

“What this indicates to me is that it was obvious to Monsanto that there was evidence of carcinogenicity,” said Peter Infante, an epidemiologist who worked for more than 24 years for the U.S. government studying cancer risks to workers from exposure to toxic substances. “It would seem to me that Monsanto does not like the public to be informed of the cancer hazard.”

“What this indicates to me is that it was obvious to Monsanto that there was evidence of carcinogenicity.”

After the IARC ruling, a storm of protest did erupt from various individuals and organizations alongside Monsanto’s howls of indignant outrage. Some have questioned the wisdom of U.S. funding for IARC and Monsanto has perpetuated a false narrative that the chairman of the IARC working group withheld critical information from the team.

The document trail, which includes internal emails, memos and other communications obtained from Monsanto by plaintiffs’ attorneys through litigation pending in the U.S., makes clear that the debate over, and challenge to, IARC’s classification did not sprout authentically from a variety of voices, but rather was manufactured by Monsanto in advance of IARC’s decision and continued afterward. The goal was—and is—to convince regulators to discount the findings of the team of independent scientific experts who made up the IARC team that examined glyphosate.

The internal records obtained through litigation, combined with documents obtained through Freedom of Information Act (FOIA) and state records requests also show that the actions employed to discredit IARC were part of a decades-long pattern of deceptive tactics by Monsanto to persuade regulators, lawmakers and members of the press and public that glyphosate and Roundup are safe. The company has used these tactics multiple times over the years to try to discredit several scientists whose research has found harmful effects associated with glyphosate.

“Orchestrate Outcry”

The IARC attack plan, which was laid out in a February 2015 memo, involved not only Monsanto’s internal PR people, scientists and marketing experts, but a range of outside industry players. Various individuals were assigned tasks. The “strategies and tactics” included:

“Identify/request third-party experts to blog, op/ed, tweet and/or link, repost, retweet, etc.” The documents show one such “expert,” academic Henry Miller, was provided a draft article to submit to Forbes for publication under his name with no mention of Monsanto’s involvement. Forbes learned of the deceit last month and severed relations with Miller.

“Inform/Inoculate/Engage Industry Partners”—Notably the industry partners listed included three organizations that purport to be independent of Monsanto but have long been seen by critics as front groups for the company—Monsanto named Academics Review and the Genetic Literacy Project, both based in the U.S. and Sense About Science, which has run operations in the United Kingdom and the U.S., as groups to help with its mission. In fact, Sense About Science was the group identified by Monsanto to lead the industry response and “provide a platform for IARC observers.” The groups did as Monsanto planned, posting scathing attacks on IARC on their websites.

Engagement with Regulatory Agencies—Monsanto planned for grower associations/ growers to “write regulators with an appeal that they remain focused on the science, not the politically charged decision by IARC.”

“Push opinion leader letter to key daily newspaper on day of IARC ruling” with assistance of the Potomac Group marketing firm.

The preparedness plan also called for supporting “the development of three new papers on glyphosate focused on epidemiology and toxicology.” As planned, shortly after the IARC decision Monsanto arranged for several scientists—many of them former employees or paid consultants—to author and publish research papers supporting glyphosate safety. It was revealed through discovery documents that Monsanto discussed ghostwriting the papers. In one email, company scientist William Heydens told colleagues the company could “ghost-write” certain reports that would carry the names of outside scientists—”they would just edit & sign their names so to speak,” he wrote. He cited as an example a 2000 study that has been regarded as influential by regulators. Documents show Monsanto’s heavy writing and editing involvement in the resulting purportedly “independent” review.

Monsanto has adamantly denied ghostwriting, but one memo from August 2015 from the files of Monsanto scientist David Saltmiras actually uses that term, stating that he “ghostwrote cancer review paper Greim et al (2015)…” referring to a paper that showed authorship by German scientist Helmut Greim along with Saltmiras. (Monsanto has acknowledged that Greim worked as a consultant to the company with part of his job being to publish peer-reviewed data on glyphosate).

Another internal email illustrates the writing by a Monsanto scientist of a research paper titled “Developmental and Reproductive Outcomes… after Glyphosate Exposure.” The scientist, Donna Farmer, did extensive work, including what she called a “cut and paste” of certain information. But her name was not included as an author before the paper was submitted to a journal. The published version concluded there was “no solid evidence linking glyphosate exposure to adverse developmental or reproductive effects.”

The record also shows that well before IARC, Monsanto recruited networks of academic scientists in the U.S and Europe who have defended Monsanto’s products, including its weed killer, without declaring their collaborations with Monsanto. And that these silent soldiers helped Monsanto discredit scientists who reported research showing harm associated with glyphosate and Roundup, including working at Monsanto’s bidding to get one damaging study by French scientist Gilles-Éric Séralini retracted from a scientific journal where it was published in September 2012. The company even discounted concerns by one of its own paid consultants who found evidence of glyphosate’s genotoxicity and refused to do the additional tests he recommended.

If what Monsanto says is true, that glyphosate is so very safe, and that there is no evidence it causes cancer or other health problems, then why all the smoke and mirrors? Why would the company need to ghostwrite research papers to present to regulators? Why would Monsanto need to establish networks of scientists to promote glyphosate safety and to tear down scientists whose research raises concerns? Why would Monsanto try to block a review of glyphosate by the U.S. ATSDR?

Two committees of the European Parliament have scheduled a hearing for Oct. 11 in Brussels to delve into these and other questions as the European Commission faces a looming deadline for making a decision on the re-authorization of glyphosate before the end of 2017.

Lawmakers should take note of evidence that their own food safety agency appears to have dropped the ball on independent assessments of glyphosate research. Records show that the European Food Safety Authority (EFSA) dismissed a study linking Monsanto’s weed killer to cancer at the advice of an EPA official who Monsanto deemed “useful” and who is part of a probe now into possible collusion between the EPA and Monsanto.

They should also pay heed to news that EFSA based its recommendation on glyphosate on a report that copied and pasted analyses from a Monsanto study.

Monsanto Chairman Hugh Grant was invited to address the Parliament meeting in October, but declined to appear or to send anyone else from Monsanto. Dr. Roland Solecki, head of chemical safety for the German Federal Institute for Risk Assessment (BfR), has also declined, according to organizers. I do plan to participate, as will a representative from IARC and several others.

Throughout this debate, it is worthwhile to remember that the concerns about glyphosate safety have deep roots that date all the way back to at least 1985 when EPA toxicologists looked at data showing rare tumors in mice dosed with glyphosate and determined that glyphosate was “possibly carcinogenic to humans.”

Big Week for Big Ag Players Monsanto and Dow

An array of GMO and pesticide critics spoke out at Monsanto Co.’s annual meeting of shareholders on Friday, Jan. 29 in the company’s hometown of Creve Coeur, Missouri, calling on the company to address concerns about the company’s genetically engineered crop products and the glyphosate-based Roundup herbicide used on those crops.

Shareholder representatives, as well as others from outside organizations, told Monsanto Chairman and CEO Hugh Grant that the company should take several steps, including reporting on any plans to mitigate risks to human health and the environment tied to Roundup and its main ingredient, glyphosate. In March 2015, the World Health Organization’s cancer experts classified glyphosate as “probably carcinogenic to humans.” And Monsanto is facing numerous lawsuits filed by farmworkers and others who say Roundup caused their cancers.

“Given that about half of Monsanto’s revenue comes from Roundup and other glyphosate-based herbicides, the labeling of the company’s core product as ‘probably carcinogenic’ is not a healthy boost for the company’s prospects,” John Harrington, CEO of Harrington Investments, said in a statement. Harrington Investments provide investment advisory services with a focus on environmental and social objectives, and has an active shareholder advocacy program.

Along with Harrington Investments, representatives from the Organic Consumers Association, Moms Across America, SumofUs, Women’s International League for Peace and Freedom, and GMO Free Midwest attended the meeting to protest the company’s promotion of Roundup, which the protesters say is tied to a range of diseases.

The group told Monsanto’s Grant that there are an increasing number of independent studies associating glyphosate with cancer, birth defects, kidney disease, and hormone disruption.

Grant deflected the criticisms and said that both glyphosate and GMOs are proven safe: “This is the 20th year of planting GMOs,” said Grant. “Four billion acres have been planted on the planet… without a single health issue. These are the most widely tested products that the food industry has ever seen.”

Monsanto brings in roughly $5 billion a year in revenues from sales of Roundup and related products.

Doctors and scientists have raised concerns about health trends in areas where farm workers and communities, such as Hawaii and Argentina, have high exposures to the chemicals used on Roundup Ready crops, which have been genetically engineered to tolerate being sprayed with glyphosate.

A federal appellate court has awarded a victory to Dow AgroSciences in the company’s controversial bid to bring a new weedkiller to U.S. farmlands. The new herbicide, branded Enlist Duo, combines glyphosate and 2,4-D, both of which have been linked to cancer and other health problems.

The Chicago Tribune reported that the 9th U.S. Circuit Court of Appeals rejected the U.S. Environmental Protection Agency’s request to vacate its own scientists’ 2014 approval of the Dow weedkiller without detailing the reason behind the order.

Dow’s new herbicide is designed to address widespread herbicide resistance that has taken hold on roughly 60 million acres of U.S. farmland after widespread use of glyphosate. Glyphosate, the primary ingredient in Monsanto Co.’s Roundup, became pervasive in production of corn, soybeans, cotton and other crops after Monsanto genetically engineered crops to withstand direct dousing of the chemical.